Specialist for Technical Research, Development & Regulatory Documentation in Medical Technology - training eligible for funding

In just 10 weeks (part-time), you will learn how to provide technical, regulatory and documentary support for medical device development processes - from the idea to the market launch - as an employee under the Qualification Opportunities Act (QCG) or as a jobseeker with an education voucher.

You understand how technical innovations are implemented, validated and documented for approvals in accordance with standards.

Ideal for an industry change from automotive to medical technology.

Target group

This training is aimed at:
- Specialists from research, development or project management in medical technology and the life sciences industry
- Job seekers with technical or scientific professional experience
- Career changers with an interest in regulatory-technical documentation

Contents of the further training

Module 1 - Development, Documentation & QM Basics (Days 1-6)
Day 1 - Technical Development & Regulatory Integration
Day 2 - Technical Documentation in the Development Process
Day 3 - Conformity Assessment and QM Introduction
Day 4 - QM Documentation and Life Cycle Management
Day 5 - QM Integration
Day 6 - Risk Management and Design Control

Module 2 - Global Market Access, Labelling & Technical Product File (days 7-12)
Day 7 - Labelling and Digitisation
Day 8 - International Requirements (USA)
Day 9 - International Requirements (MSDAP & Asia)
Day 10 - International Requirements (LATAM)
Day 11 - Practical Workshop Development File & Technical Documentation

Module 3 - Clinical Evidence, Studies & Post-Market Activities (Days 13-18)
Day 12 - Verification, Validation & Fundamentals of Clinical Evaluation
Day 13 - Clinical Evaluation (CEP & CER)
Day 14 - Study Design and GCP
Day 15 - Clinical Data & PMCF I
Day 16 - PMCF II
Day 17 - Clinical Validation Practice Workshop I
Day 18 - Clinical Validation Practice Workshop II

Module 4 - Technical & Regulatory Writing & Completion (Days 19-20)
Day 19 - Technical & Regulatory Writing Workshop
Day 20 - Writing Workshop II & Completion

Prerequisites for participation
- Completed studies or professional experience in the technical, scientific or medical field
- Good knowledge of English & basic PC skills
- Participation after aptitude assessment in the counselling interview
- Career prospects
- After completion you will be qualified for activities in:

Research & development of medical devices
Regulatory affairs / technical documentation
Quality & process management
Clinical evaluation & validation documentation

Costs
The training is AZAV-certified and can be funded up to 100% by the Federal Employment Agency or the job centre (e.g. via an education voucher).
For employees, funding is possible in accordance with the Qualification Opportunities Act (§82 SGB III).
If approved, you will not incur any costs.

More information